Gastric bypass versus best medical treatment for diabetic kidney disease: 5 years follow up of a single-centre open label randomised controlled trial

Ricardo V. Cohen; Tiago Veiga Pereira; Cristina Mamédio Aboud; Tarissa Beatrice Zanata Petry; José Luis Lopes Correa; Carlos Aurélio Schiavon; Carlos Eduardo Pompílio; Fernando Nogueira Quirino Pechy; Ana Carolina Calmon da Costa Silva; Lívia Porto Cunha da Silveira; Pedro Paulo de Paris Caravatto; Helio Halpern; Frederico de Lima Jacy Monteiro; Bruno da Costa Martins; Rogerio Kuga; Thais Mantovani Sarian Palumbo; Allon N. Friedman; Carel W. le Roux

doi:10.1016/j.eclinm.2022.101725

Gastric bypass versus best medical treatment for diabetic kidney disease: 5 years follow up of a single-centre open label randomised controlled trial

Ricardo V. Cohen, Tiago Veiga Pereira, Cristina Mamédio Aboud, Tarissa Beatrice Zanata Petry, José Luis Lopes Correa, Carlos Aurélio Schiavon, Carlos Eduardo Pompílio, Fernando Nogueira Quirino Pechy, Ana Carolina Calmon da Costa Silva, Lívia Porto Cunha da Silveira, Pedro Paulo de Paris Caravatto, Helio Halpern, Frederico de Lima Jacy Monteiro, Bruno da Costa Martins, Rogerio Kuga, Thais Mantovani Sarian Palumbo, Allon N. Friedman, Carel W. le Roux

Research output: Contribution to journal › Article › peer-review

15 Citations (Scopus)

73 Downloads (Pure)

Abstract

Background: We compared the albuminuria-lowering effects of Roux-en-Y gastric bypass (RYGB) to best medical treatment in patients with diabetic kidney disease and obesity to determine which treatment is better. Methods: A 5 year, open-label, single-centre, randomised trial studied patients with diabetic kidney disease and class I obesity after 1:1 randomization to best medical treatment (n = 49) or RYGB (n = 51). The primary outcome was the proportion of patients achieving remission of microalbuminuria after 5 years. Secondary outcomes included improvements in diabetic kidney disease, glycemic control, quality of life, and safety. For efficacy outcomes, we performed an intention-to-treat (ITT) analysis. This study was registered with ClinicalTrials.gov, NCT01821508. Findings: 88% of patients (44 per arm) completed 5-year follow-up. Remission of albuminuria occurred in 59.6% (95% CI = 45.5–73.8) after best medical treatment and 69.7% (95% CI = 59.6–79.8) after RYGB (risk difference: 10%, 95% CI, −7 to 27, P = 0.25). Patients after RYGB were twice as likely to achieve an HbA1c ≤ 6.5% (60.2% versus 25.4%, risk difference, 34.9%; 95% CI = 15.8–53.9, P < 0.001). Quality of life after five years measured by the 36-Item Short Form Survey questionnaire (standardized to a 0-to-100 scale) was higher in the RYGB group than in the best medical treatment group for several domains. The mean differences were 13.5 (95% CI, 5.5–21.6, P = 0.001) for general health, 19.7 (95% CI, 9.1–30.3, P < 0.001) for pain, 6.1 (95% CI, −4.8 to 17.0, P = 0.27) for social functioning, 8.3 (95% CI, 0.23 to 16.3, P = 0.04) for emotional well-being, 12.2 (95% CI, 3.9–20.4, P = 0.004) for vitality, 16.8 (95% CI, −0.75 to 34.4, P = 0.06) for mental health, 21.8 (95% CI, 4.8–38.7, P = 0.01) for physical health and 11.1 (95% CI, 2.24–19.9, P = 0.01) for physical functioning. Serious adverse events were experienced in 7/46 (15.2%) after best medical treatment and 11/46 patients (24%) after RYGB (P = 0.80). Interpretation: Albuminuria remission was not statistically different between best medical treatment and RYGB after 5 years in participants with diabetic kidney disease and class 1 obesity, with 6–7 in ten patients achieving remission of microalbuminuria (uACR <30 mg/g) in both groups. RYGB was superior in improving glycemia, diastolic blood pressure, lipids, body weight, and quality of life. Funding: The study was supported by research grants from Johnson & Johnson Brasil, Oswaldo Cruz German Hospital, and by grant 12/YI/B2480 from Science Foundation Ireland (Dr le Roux) and grant 2015-02733 from the Swedish Medical Research Council (Dr le Roux). Dr Pereira was funded by the Chevening Scholarship Programme (Foreign and Commonwealth Office, UK).

Original language	English
Article number	101725
Pages (from-to)	101725
Number of pages	11
Journal	EClinicalMedicine
Volume	53
Early online date	11 Nov 2022
DOIs	https://doi.org/10.1016/j.eclinm.2022.101725
Publication status	Published (in print/issue) - Nov 2022

Bibliographical note

Funding Information:
During the study, Dr Cohen reported receiving grants from Johnson & Johnson Medical Brasil. Dr Petry reported receiving grants from Johnson &Johnson Medical Brasil during the study. Dr Schiavon reported receiving grants from Ethicon and personal fees from Johnson & Johnson Brasil outside the submitted work. During the study, Dr Pompilio reported receiving grants from Johnson & Johnson Medical Brasil. Dr Sarian reported receiving grants from Johnson & Johnson Medical Brasil. Dr Nogueira Pechy reported receiving grants from Johnson & Johnson Medical Brasil and honoraria for lectures, Johnson&Johnson and Medtronic. Dr Porto da Silveira reported receiving grants from Johnson & Johnson Medical Brasil and honoraria for lectures, Johnson&Johnson and Medtronic. Dr Friedman reported partcipating on a Data.Safety Monitoring Board or Advisory Board for Gila Therapeutics and GI Dynamics, leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid for the International Society of Renal Nutrition and Metabolism and Editorial board- Journal of Renal Nutrition Dr le Roux reported receiving grants from Science Foundation Ireland, Health Research Board, European Federation for Study of Diabetes, and the Swedish Research Council during the conduct of the study and receiving an honorarium for lectures and scientific advisory board from Novo Nordisk, GI Dynamics, Sanofi, Johnson & Johnson Brasil, Keyron, Herbalife, and Boehringer Ingelheim outside the submitted work. Dr. Pereira reported receiving consulting fees from Novartis unrelated to the study. All other authors declare no competing interests.

Publisher Copyright:
© 2022 The Author(s)

Keywords

Bariatric surgery
Type 2 diabetes
Diabetic kidney disease
Obesity

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1016/j.eclinm.2022.101725

1-s2.0-S2589537022004552-mainFinal published version, 982 KBLicence: CC BY-NC-ND

Cite this

Cohen, R. V., Pereira, T. V., Aboud, C. M., Zanata Petry, T. B., Lopes Correa, J. L., Schiavon, C. A., Pompílio, C. E., Quirino Pechy, F. N., Calmon da Costa Silva, A. C., Cunha da Silveira, L. P., Paulo de Paris Caravatto, P., Halpern, H., de Lima Jacy Monteiro, F., da Costa Martins, B., Kuga, R., Sarian Palumbo, T. M., Friedman, A. N., & le Roux, C. W. (2022). Gastric bypass versus best medical treatment for diabetic kidney disease: 5 years follow up of a single-centre open label randomised controlled trial. EClinicalMedicine, 53, 101725. Article 101725. https://doi.org/10.1016/j.eclinm.2022.101725

@article{c2b59d0c3a7446a49876c3712de0e97c,

title = "Gastric bypass versus best medical treatment for diabetic kidney disease: 5 years follow up of a single-centre open label randomised controlled trial",

abstract = "Background: We compared the albuminuria-lowering effects of Roux-en-Y gastric bypass (RYGB) to best medical treatment in patients with diabetic kidney disease and obesity to determine which treatment is better. Methods: A 5 year, open-label, single-centre, randomised trial studied patients with diabetic kidney disease and class I obesity after 1:1 randomization to best medical treatment (n = 49) or RYGB (n = 51). The primary outcome was the proportion of patients achieving remission of microalbuminuria after 5 years. Secondary outcomes included improvements in diabetic kidney disease, glycemic control, quality of life, and safety. For efficacy outcomes, we performed an intention-to-treat (ITT) analysis. This study was registered with ClinicalTrials.gov, NCT01821508. Findings: 88% of patients (44 per arm) completed 5-year follow-up. Remission of albuminuria occurred in 59.6% (95% CI = 45.5–73.8) after best medical treatment and 69.7% (95% CI = 59.6–79.8) after RYGB (risk difference: 10%, 95% CI, −7 to 27, P = 0.25). Patients after RYGB were twice as likely to achieve an HbA1c ≤ 6.5% (60.2% versus 25.4%, risk difference, 34.9%; 95% CI = 15.8–53.9, P < 0.001). Quality of life after five years measured by the 36-Item Short Form Survey questionnaire (standardized to a 0-to-100 scale) was higher in the RYGB group than in the best medical treatment group for several domains. The mean differences were 13.5 (95% CI, 5.5–21.6, P = 0.001) for general health, 19.7 (95% CI, 9.1–30.3, P < 0.001) for pain, 6.1 (95% CI, −4.8 to 17.0, P = 0.27) for social functioning, 8.3 (95% CI, 0.23 to 16.3, P = 0.04) for emotional well-being, 12.2 (95% CI, 3.9–20.4, P = 0.004) for vitality, 16.8 (95% CI, −0.75 to 34.4, P = 0.06) for mental health, 21.8 (95% CI, 4.8–38.7, P = 0.01) for physical health and 11.1 (95% CI, 2.24–19.9, P = 0.01) for physical functioning. Serious adverse events were experienced in 7/46 (15.2%) after best medical treatment and 11/46 patients (24%) after RYGB (P = 0.80). Interpretation: Albuminuria remission was not statistically different between best medical treatment and RYGB after 5 years in participants with diabetic kidney disease and class 1 obesity, with 6–7 in ten patients achieving remission of microalbuminuria (uACR <30 mg/g) in both groups. RYGB was superior in improving glycemia, diastolic blood pressure, lipids, body weight, and quality of life. Funding: The study was supported by research grants from Johnson & Johnson Brasil, Oswaldo Cruz German Hospital, and by grant 12/YI/B2480 from Science Foundation Ireland (Dr le Roux) and grant 2015-02733 from the Swedish Medical Research Council (Dr le Roux). Dr Pereira was funded by the Chevening Scholarship Programme (Foreign and Commonwealth Office, UK).",

keywords = "Bariatric surgery, Type 2 diabetes, Diabetic kidney disease, Obesity",

author = "Cohen, {Ricardo V.} and Pereira, {Tiago Veiga} and Aboud, {Cristina Mam{\'e}dio} and {Zanata Petry}, {Tarissa Beatrice} and {Lopes Correa}, {Jos{\'e} Luis} and Schiavon, {Carlos Aur{\'e}lio} and Pomp{\'i}lio, {Carlos Eduardo} and {Quirino Pechy}, {Fernando Nogueira} and {Calmon da Costa Silva}, {Ana Carolina} and {Cunha da Silveira}, {L{\'i}via Porto} and {Paulo de Paris Caravatto}, Pedro and Helio Halpern and {de Lima Jacy Monteiro}, Frederico and {da Costa Martins}, Bruno and Rogerio Kuga and {Sarian Palumbo}, {Thais Mantovani} and Friedman, {Allon N.} and {le Roux}, {Carel W.}",

note = "Funding Information: During the study, Dr Cohen reported receiving grants from Johnson & Johnson Medical Brasil. Dr Petry reported receiving grants from Johnson &Johnson Medical Brasil during the study. Dr Schiavon reported receiving grants from Ethicon and personal fees from Johnson & Johnson Brasil outside the submitted work. During the study, Dr Pompilio reported receiving grants from Johnson & Johnson Medical Brasil. Dr Sarian reported receiving grants from Johnson & Johnson Medical Brasil. Dr Nogueira Pechy reported receiving grants from Johnson & Johnson Medical Brasil and honoraria for lectures, Johnson&Johnson and Medtronic. Dr Porto da Silveira reported receiving grants from Johnson & Johnson Medical Brasil and honoraria for lectures, Johnson&Johnson and Medtronic. Dr Friedman reported partcipating on a Data.Safety Monitoring Board or Advisory Board for Gila Therapeutics and GI Dynamics, leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid for the International Society of Renal Nutrition and Metabolism and Editorial board- Journal of Renal Nutrition Dr le Roux reported receiving grants from Science Foundation Ireland, Health Research Board, European Federation for Study of Diabetes, and the Swedish Research Council during the conduct of the study and receiving an honorarium for lectures and scientific advisory board from Novo Nordisk, GI Dynamics, Sanofi, Johnson & Johnson Brasil, Keyron, Herbalife, and Boehringer Ingelheim outside the submitted work. Dr. Pereira reported receiving consulting fees from Novartis unrelated to the study. All other authors declare no competing interests. Publisher Copyright: {\textcopyright} 2022 The Author(s)",

year = "2022",

month = nov,

doi = "10.1016/j.eclinm.2022.101725",

language = "English",

volume = "53",

pages = "101725",

journal = "EClinicalMedicine",

issn = "2589-5370",

publisher = "Elsevier",

}

Cohen, RV, Pereira, TV, Aboud, CM, Zanata Petry, TB, Lopes Correa, JL, Schiavon, CA, Pompílio, CE, Quirino Pechy, FN, Calmon da Costa Silva, AC, Cunha da Silveira, LP, Paulo de Paris Caravatto, P, Halpern, H, de Lima Jacy Monteiro, F, da Costa Martins, B, Kuga, R, Sarian Palumbo, TM, Friedman, AN & le Roux, CW 2022, 'Gastric bypass versus best medical treatment for diabetic kidney disease: 5 years follow up of a single-centre open label randomised controlled trial', EClinicalMedicine, vol. 53, 101725, pp. 101725. https://doi.org/10.1016/j.eclinm.2022.101725

TY - JOUR

T1 - Gastric bypass versus best medical treatment for diabetic kidney disease: 5 years follow up of a single-centre open label randomised controlled trial

AU - Cohen, Ricardo V.

AU - Pereira, Tiago Veiga

AU - Aboud, Cristina Mamédio

AU - Zanata Petry, Tarissa Beatrice

AU - Lopes Correa, José Luis

AU - Schiavon, Carlos Aurélio

AU - Pompílio, Carlos Eduardo

AU - Quirino Pechy, Fernando Nogueira

AU - Calmon da Costa Silva, Ana Carolina

AU - Cunha da Silveira, Lívia Porto

AU - Paulo de Paris Caravatto, Pedro

AU - Halpern, Helio

AU - de Lima Jacy Monteiro, Frederico

AU - da Costa Martins, Bruno

AU - Kuga, Rogerio

AU - Sarian Palumbo, Thais Mantovani

AU - Friedman, Allon N.

AU - le Roux, Carel W.

N1 - Funding Information: During the study, Dr Cohen reported receiving grants from Johnson & Johnson Medical Brasil. Dr Petry reported receiving grants from Johnson &Johnson Medical Brasil during the study. Dr Schiavon reported receiving grants from Ethicon and personal fees from Johnson & Johnson Brasil outside the submitted work. During the study, Dr Pompilio reported receiving grants from Johnson & Johnson Medical Brasil. Dr Sarian reported receiving grants from Johnson & Johnson Medical Brasil. Dr Nogueira Pechy reported receiving grants from Johnson & Johnson Medical Brasil and honoraria for lectures, Johnson&Johnson and Medtronic. Dr Porto da Silveira reported receiving grants from Johnson & Johnson Medical Brasil and honoraria for lectures, Johnson&Johnson and Medtronic. Dr Friedman reported partcipating on a Data.Safety Monitoring Board or Advisory Board for Gila Therapeutics and GI Dynamics, leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid for the International Society of Renal Nutrition and Metabolism and Editorial board- Journal of Renal Nutrition Dr le Roux reported receiving grants from Science Foundation Ireland, Health Research Board, European Federation for Study of Diabetes, and the Swedish Research Council during the conduct of the study and receiving an honorarium for lectures and scientific advisory board from Novo Nordisk, GI Dynamics, Sanofi, Johnson & Johnson Brasil, Keyron, Herbalife, and Boehringer Ingelheim outside the submitted work. Dr. Pereira reported receiving consulting fees from Novartis unrelated to the study. All other authors declare no competing interests. Publisher Copyright: © 2022 The Author(s)

PY - 2022/11

Y1 - 2022/11

N2 - Background: We compared the albuminuria-lowering effects of Roux-en-Y gastric bypass (RYGB) to best medical treatment in patients with diabetic kidney disease and obesity to determine which treatment is better. Methods: A 5 year, open-label, single-centre, randomised trial studied patients with diabetic kidney disease and class I obesity after 1:1 randomization to best medical treatment (n = 49) or RYGB (n = 51). The primary outcome was the proportion of patients achieving remission of microalbuminuria after 5 years. Secondary outcomes included improvements in diabetic kidney disease, glycemic control, quality of life, and safety. For efficacy outcomes, we performed an intention-to-treat (ITT) analysis. This study was registered with ClinicalTrials.gov, NCT01821508. Findings: 88% of patients (44 per arm) completed 5-year follow-up. Remission of albuminuria occurred in 59.6% (95% CI = 45.5–73.8) after best medical treatment and 69.7% (95% CI = 59.6–79.8) after RYGB (risk difference: 10%, 95% CI, −7 to 27, P = 0.25). Patients after RYGB were twice as likely to achieve an HbA1c ≤ 6.5% (60.2% versus 25.4%, risk difference, 34.9%; 95% CI = 15.8–53.9, P < 0.001). Quality of life after five years measured by the 36-Item Short Form Survey questionnaire (standardized to a 0-to-100 scale) was higher in the RYGB group than in the best medical treatment group for several domains. The mean differences were 13.5 (95% CI, 5.5–21.6, P = 0.001) for general health, 19.7 (95% CI, 9.1–30.3, P < 0.001) for pain, 6.1 (95% CI, −4.8 to 17.0, P = 0.27) for social functioning, 8.3 (95% CI, 0.23 to 16.3, P = 0.04) for emotional well-being, 12.2 (95% CI, 3.9–20.4, P = 0.004) for vitality, 16.8 (95% CI, −0.75 to 34.4, P = 0.06) for mental health, 21.8 (95% CI, 4.8–38.7, P = 0.01) for physical health and 11.1 (95% CI, 2.24–19.9, P = 0.01) for physical functioning. Serious adverse events were experienced in 7/46 (15.2%) after best medical treatment and 11/46 patients (24%) after RYGB (P = 0.80). Interpretation: Albuminuria remission was not statistically different between best medical treatment and RYGB after 5 years in participants with diabetic kidney disease and class 1 obesity, with 6–7 in ten patients achieving remission of microalbuminuria (uACR <30 mg/g) in both groups. RYGB was superior in improving glycemia, diastolic blood pressure, lipids, body weight, and quality of life. Funding: The study was supported by research grants from Johnson & Johnson Brasil, Oswaldo Cruz German Hospital, and by grant 12/YI/B2480 from Science Foundation Ireland (Dr le Roux) and grant 2015-02733 from the Swedish Medical Research Council (Dr le Roux). Dr Pereira was funded by the Chevening Scholarship Programme (Foreign and Commonwealth Office, UK).

AB - Background: We compared the albuminuria-lowering effects of Roux-en-Y gastric bypass (RYGB) to best medical treatment in patients with diabetic kidney disease and obesity to determine which treatment is better. Methods: A 5 year, open-label, single-centre, randomised trial studied patients with diabetic kidney disease and class I obesity after 1:1 randomization to best medical treatment (n = 49) or RYGB (n = 51). The primary outcome was the proportion of patients achieving remission of microalbuminuria after 5 years. Secondary outcomes included improvements in diabetic kidney disease, glycemic control, quality of life, and safety. For efficacy outcomes, we performed an intention-to-treat (ITT) analysis. This study was registered with ClinicalTrials.gov, NCT01821508. Findings: 88% of patients (44 per arm) completed 5-year follow-up. Remission of albuminuria occurred in 59.6% (95% CI = 45.5–73.8) after best medical treatment and 69.7% (95% CI = 59.6–79.8) after RYGB (risk difference: 10%, 95% CI, −7 to 27, P = 0.25). Patients after RYGB were twice as likely to achieve an HbA1c ≤ 6.5% (60.2% versus 25.4%, risk difference, 34.9%; 95% CI = 15.8–53.9, P < 0.001). Quality of life after five years measured by the 36-Item Short Form Survey questionnaire (standardized to a 0-to-100 scale) was higher in the RYGB group than in the best medical treatment group for several domains. The mean differences were 13.5 (95% CI, 5.5–21.6, P = 0.001) for general health, 19.7 (95% CI, 9.1–30.3, P < 0.001) for pain, 6.1 (95% CI, −4.8 to 17.0, P = 0.27) for social functioning, 8.3 (95% CI, 0.23 to 16.3, P = 0.04) for emotional well-being, 12.2 (95% CI, 3.9–20.4, P = 0.004) for vitality, 16.8 (95% CI, −0.75 to 34.4, P = 0.06) for mental health, 21.8 (95% CI, 4.8–38.7, P = 0.01) for physical health and 11.1 (95% CI, 2.24–19.9, P = 0.01) for physical functioning. Serious adverse events were experienced in 7/46 (15.2%) after best medical treatment and 11/46 patients (24%) after RYGB (P = 0.80). Interpretation: Albuminuria remission was not statistically different between best medical treatment and RYGB after 5 years in participants with diabetic kidney disease and class 1 obesity, with 6–7 in ten patients achieving remission of microalbuminuria (uACR <30 mg/g) in both groups. RYGB was superior in improving glycemia, diastolic blood pressure, lipids, body weight, and quality of life. Funding: The study was supported by research grants from Johnson & Johnson Brasil, Oswaldo Cruz German Hospital, and by grant 12/YI/B2480 from Science Foundation Ireland (Dr le Roux) and grant 2015-02733 from the Swedish Medical Research Council (Dr le Roux). Dr Pereira was funded by the Chevening Scholarship Programme (Foreign and Commonwealth Office, UK).

KW - Bariatric surgery

KW - Type 2 diabetes

KW - Diabetic kidney disease

KW - Obesity

UR - http://www.scopus.com/inward/record.url?scp=85142667328&partnerID=8YFLogxK

U2 - 10.1016/j.eclinm.2022.101725

DO - 10.1016/j.eclinm.2022.101725

M3 - Article

C2 - 36467457

SN - 2589-5370

VL - 53

SP - 101725

JO - EClinicalMedicine

JF - EClinicalMedicine

M1 - 101725

ER -

Gastric bypass versus best medical treatment for diabetic kidney disease: 5 years follow up of a single-centre open label randomised controlled trial

Abstract

Bibliographical note

Keywords

UN SDGs

Access to Document

Other files and links

Fingerprint

Cite this